Likert and visual analogue (VAS) pain scales, patient and physician global assessment scales and the physician's assessment of tenderness, swelling and erythema of the most affected joint will be collected during every gouty arthritis flare and at the end of the study.

PK assessments at various time points will be carried out to characterize the PK properties of the PFS form of canakinumab, as well as provide supporting data in the interpretation of any immunogenicity findings.

Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Eligibility

Ages Eligible for Study:

18 Years to 85 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

Compliance and completion of the canakinumab PFS core study

Unchanged significant clinical medical history from entry into core study

Exclusion criteria:

Physician judgment of unsuitability for the study

Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431638

United States: Food and Drug AdministrationBelgium: Ministry of Social Affairs, Public Health and the EnvironmentCanada: Canadian Institutes of Health ResearchGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyLithuania: State Medicine Control Agency - Ministry of Health